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Completed

NCT Number: NCT07044245

Effect of Low Level Diode Laser Biostimulation on Implant Stability

Tooth loss is accompanied by bone loss in all dimensions, so preservation of the bone is mandatory for placement of dental implant, as bone quantity and quality are predictive factors in achieving proper primary stability. Low level bio stimulation has stimulatory effect on bone cells so it can be used in immediate implants to increase bone formation around the implant.

the Aim of this study is to evaluate the effect of low-level diode laser Biostimulation on immediate implants in maxillary premolars.

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Key information

Conditions

Immediate Implant Placement Biostimulation LASER

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

20 patients with unrestorable maxillary premolars were included in the study treated with immediate implants. Patients were divided into two groups (n=10). Group 1 Received immediate implant with low level diode laser application (study), and group 2 received immediate implant without laser application (control). Preoperative clinical and radiographic evaluation, immediate post operative and after 4 months radiographic evaluation to assess stability and bone density around the implant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unrestorable maxillary premolars with sufficient bone quantity to receive the dental implant.
  • Age ranging from 25-45.
  • Patients with no local or systemic pathology that can interfere with normal wound healing.
  • Non- smokers.
  • Patients that are properly motivated to complete follow up visits.
  • Patients with adequate oral hygiene or willing to improve their oral hygiene to ensure uncompromised wound healing.

Exclusion criteria

  • Patients with uncontrolled medical condition that can affect surgical outcome or bone and wound healing. (ex: diabetes mellitus)
  • Patients with periapical pathology that may contraindicate immediate implant placement.
  • History of receiving irradiation in head and neck region

Treatment and study plan

immediate maxillary premolar implant placement with no subsequent laser Biostimulation

Procedure

Sham laser application

immediate maxillary premolar implant placement with subsequent laser Biostimulation

Procedure

low lever biostimulation was performed on two consecutive sessions each of 100 s. First session was carried out immediately on surgery time after implant placement, using a diode laser Photo-biomodulation tip in a continuous wave and non-contact mode

Primary outcomes

  1. Implant Stability Assessment using Radio frequency analysis

    Time frame: 4 month

    Secondary implant stability analysis was performed 4-months after implant placement. Radio frequency analysis (RFA) was performed using Osstell device (Integration diagnostic Ltd. Company, Sävedalen, Sweden). Primary and secondary implant stability were analyzed and compared. The use of the Osstell and ISQ values were obtained by a blinded operator

Secondary outcomes

  1. Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.

    Time frame: 4 months

    A postoperative CBCT will be taken within 24 hours of implant placement followed by a 6-months scan, and values will be compared with the preoperative record. The assessment will be conducted using the tools on the "On Demand 3D App." Software*. The following criteria will be assessed:

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of the Effect of Low Level Diode Laser Biostimulation on Implant Stability in Immediate Implant in The Maxillary Premolars. A Randomized Clinical Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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